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Intravitreal Triamcinolone Acetonide for Diabetic Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00476918
First received: May 21, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

Efficacy duration of triamcinolone acetonide (steroid) for treatment of diabetic macular edema. Furthermore, dosage dependency of triamcinolone acetonide comparing a high dosage versus a low dosage.


Condition Intervention Phase
Diabetic Retinopathy
Diabetic Macular Edema
 Drug: Intravitreal injection (triamcinolone acetonide)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Dosage Dependency of Intravitreal Triamcinolone Acetonide for Treatment of Diabetic Macular Edema

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Visual acuity, no of treatments, duration of efficacy [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • intraocular pressure, retinal thickness [ Time Frame: 12 months ]

Estimated Enrollment: 60
Study Start Date: July 2006
Estimated Study Completion Date: December 2007
Detailed Description:

Patients with diabetic retinopathy suffer from visual acuity loss caused by diabetic macular edema. Intravitreal injected Triamcinolone Acetonide (steroid) reduces macular edema and increases visual acuity. The duration of its effect is however limited. Therefore, several injections are necessary.

In this study a dosage dependency of triamcinolone acetonide (high dosage vs low dosage) is performed. The primary outcome parameters are the number of treatments and the efficacy of each injection.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetic macular edema and visual acuity between 20/200 and 20/40 age over 18 years

Exclusion Criteria:

  • recent treatment with laser photocoagulation or intravitreal drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00476918

Contacts
Contact: Ulrich HM Spandau, PhD MD +496213832242 ulrich.spandau@augen.ma.uni-heidelberg.de
Contact: Anne Wickenhaeuser, MD +496213832242 anne.wickenhäuser@augen.ma.uni-heidelberg.de

Locations
Germany
Dep of Ophthalmology, University of Mannheim Recruiting
Mannheim, Germany, 68167
Principal Investigator: Ulrich HM Spandau, PhD MD            
Sponsors and Collaborators
University of Heidelberg
Investigators
Study Director: Jost Jonas, PhD MD Dep of Ophthalmology, University of Mannheim
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00476918     History of Changes
Other Study ID Numbers: 21091968, Insurance no.: 20-770-968594
Study First Received: May 21, 2007
Last Updated: May 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
diabetic macular edema
triamcinolone acetonide
intravitreal
steroid

Additional relevant MeSH terms:
Edema
Macular Edema
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Triamcinolone hexacetonide
 Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013